FDA approves CV's Ranexa in increased-dosage tablet

By Adam Kraemer

CV Therapeutics announced the Food and Drug Administration approval and U.S. product launch of the 1000 mg tablet of Ranexa (ranolazine extended-release tablets).

The approved product labeling recommends that Ranexa be initiated at 500 mg twice daily and increased to 1000 mg, as needed, based on clinical symptoms. The convenience of the 1000 mg tablets means that patients prescribed the 1000 mg twice-daily now no longer have to take—or replace—four 500 mg tablets per day.

"We are very excited to bring the added convenience of a 1000 mg tablet to the group of patients currently taking Ranexa at this dosage. While the 1000 mg dose currently represents less than 10 percent of our business, CV Therapeutics is committed to providing new options that add value for doctors and patients," said Lewis Stuart, senior vice president, commercial operations.

Ranexa is indicated for treatment of chronic angina in patients who have not achieved an adequate response with other antianginal drugs.